This is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease patients with hyperphosphatemia on hemodialysis. Patient participation in the study is approximately 10 weeks in duration.
Hyperphosphatemia is associated with abnormally high blood concentrations of phosphorus. Normally, phosphorus in the body is excreted into urine via the kidneys, but this process is impaired when renal function is reduced. Hyperphosphatemia occurs in many patients with renal insufficiency, especially those on dialysis. High blood phosphorus concentrations trigger various complications caused by phosphorous interaction with blood calcium or parathyroid hormones, and makes patients more prone to calcium deposition in soft tissues such as the coronary arteries, increasing the risk of ischemic heart disease. ILY101 is a non-absorbed, metal-free polymer that binds phosphorus in the gastrointestinal tract, allowing for excretion of phosphorus. It is therefore anticipated to ameliorate hyperphosphatemia by reducing the absorption of phosphorus from the gastrointestinal tract.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Clinical Study Site
Mobile, Alabama, United States
Clinical Study Site
Mountain View, California, United States
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Clinical Study Site
Riverside, California, United States
Clinical Study Site
San Diego, California, United States
Clinical Study Site
Thornton, Colorado, United States
Clinical Study Site
Ocala, Florida, United States
Clinical Study Site
Palm Beach Gardens, Florida, United States
Clinical Study Site
Pembroke Pines, Florida, United States
Clinical Study Site
Des Moines, Iowa, United States
Clinical Study Site
Baton Rouge, Louisiana, United States
...and 8 more locations